Important Safety Information - Enclomiphene + Supplement Blend
What is this?
This Important Safety Information summarizes the most important warnings and precautions for Enclomiphene + Supplement Blend, a compounded prescription medication that your provider has prescribed to treat for testosterone deficiency, if deemed clinically appropriate. It does not contain all possible information. You will also receive a medication guide or patient drug information sheet with your medication when it arrives from the pharmacy which contains full information about Enclomiphene + Supplement Blend. You should read all of the information that comes with your prescription before taking your medication and at each refill. It’s important to take your medication as directed by your provider and to always read your prescription label and follow your healthcare provider's instructions.
Enclomiphene + Supplement Blend is compounded by licensed pharmacists and includes the active pharmaceutical ingredients, enclomiphene (prescribed for certain men with low testosterone), Vitamin B6, Vitamin B12, L-Arginine, and Zinc Sulfate. Unless otherwise indicated, the safety information below is based on the known safety profiles of these active ingredients as used in the compounded medication.
Like all compounded medications, Enclomiphene + Supplement Blend is not FDA approved. This means that the safety, effectiveness, and quality of this medication has not been verified by the FDA, as the FDA does not verify the safety,effectiveness, and quality of any compounded drugs.
Most Serious Warnings
Enclomiphene + Supplement Blend can cause:
Blood clots in the legs, lungs, or other parts of the body
Serious vision problems, including blurred vision, floaters, partial vision loss, and rare cases of permanent damage
Hormone-sensitive cancers such as prostate or breast cancer to grow or return
Mood changes or psychiatric symptoms, including irritability, depression, or mania Call your healthcare provider right away if you develop any of these symptoms.
Who Should NOT Take Enclomiphene + Supplement Blend
Do not take Enclomiphene + Supplement Blend if you:
Use or have used illegal anabolic steroids in the past 6 months
Have active, serious heart problems (unstable angina, high-risk arrhythmia, very recent heart attack, or severe congestive heart failure)
Have active liver disease or chronic liver dysfunction with persistently abnormal liver function tests
Have a history of serious vision problems such as NAION (non-arteritic anterior ischemic optic neuropathy), central serous chorioretinopathy, or non-traumatic retinal disorders
Have active cancer that is not in remission, especially hormone-sensitive cancers such as prostate or breast cancer
Have polycythemia vera, hemochromatosis, or hematocrit >54%
Have a history of blood clotting disorders such as Factor V Leiden, Protein C/S deficiency, antithrombin III deficiency, prothrombin gene mutation, sickle cell anemia, antiphospholipid syndrome, or paroxysmal nocturnal hemoglobinuria
Have unstable psychiatric conditions requiring hospitalization in the past year
Have active pituitary or adrenal disease, dysfunction, or tumors (e.g., prolactinomas, Cushing’s syndrome, Addison’s disease)
Have known hypersensitivity to enclomiphene, zinc, vitamin B6, vitamin B12, L-Arginine or any inactive ingredients
Before Taking Enclomiphene + Supplement Blend, Tell Your Healthcare Provider if You:
Have a history of heart disease, stroke, or cardiovascular procedures
Have known liver conditions
Have blood clotting disorders or a personal/family history of blood clots
Have been diagnosed with low testosterone
Have a history of psychiatric illness such as bipolar disorder, depression, or psychosis
Are taking medications that affect hormone levels (e.g., testosterone, clomiphene, hCG, aromatase inhibitors)
Are taking medications that may interact with Enclomiphene + Supplement Blend, such as nitrates, certain antibiotics, or HIV medicines
Are taking medications for HIV called integrase strand transfer inhibitors (INSTIs), such as Biktarvy® (bictegravir, emtricitabine, and tenofovir alafenamide), Dovato® (dolutegravir and lamivudine), Triumeq® (dolutegravir, abacavir, and lamivudine), Tivicay® (dolutegravir), Isentress® (raltegravir), Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide), or Stribild® (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate)
Have eye disorders or previous episodes of vision changes
Have been diagnosed with any form of cancer
Have abnormal PSA or hematocrit test results
Take supplements marketed for testosterone or libido (e.g., DHEA, Tongkat Ali, Tribulus)
Take supplements that contain zinc, especially those with >25 mg of elemental zinc)
Possible Side Effects
Common:
Headache
Mild nausea
Decreased libido
Dizziness
Hot flashes
Breast tenderness or enlargement (rare)
Mood changes (rare)
Fatigue (rare)
Serious (seek medical care immediately):
Vision changes, floaters, or vision loss
Severe or persistent headaches
Signs of blood clots (leg swelling, chest pain, shortness of breath)
Mood changes, depression, mania, or new psychiatric symptoms
Signs of liver problems (yellowing skin/eyes, dark urine, abdominal pain)
Swelling, rapid weight gain, or fluid retention
New or worsening cancer symptoms
While Taking Enclomiphene + Supplement Blend
Tell your healthcare provider immediately if you:
Start any new medication, especially CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) or 5-alpha-reductase inhibitors (finasteride, dutasteride)
Plan surgery, including dental procedures
Resume or start testosterone, anabolic steroids, or hormone-modifying supplements
Miss doses consistently or notice reduced treatment effectiveness
Enclomiphene + Supplement Blend contains 30 mg of zinc sulfate, providing approximately 6.8 mg of elemental zinc per dose.To ensure optimal nutrient balance and avoid excessive zinc intake:
Check your multivitamin and other supplements for zinc content.
Avoid taking additional high-dose zinc supplements (especially those with >25 mg of elemental zinc) unless recommended by a healthcare provider.
Maintain a balanced diet with natural sources of zinc, such as lean meats, shellfish, nuts, and seeds.
Consult your healthcare provider before use if you have concerns about zinc intake or long-term supplementation.
Enclomiphene + Supplement Blend contains essential B vitamins at levels safe for daily use. If you have specific health concerns or take additional supplements, consult your healthcare provider.
Pregnancy and Fertility
Do not take if you are pregnant or may become pregnant. Enclomiphene may harm an unborn baby.
Enclomiphene is not for use in women.
Overdose
In case of overdose, seek medical attention immediately or contact Poison Control at 1-800-222-1222.
Missed Dosage
If you miss a dose of a daily medication, take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for the missed dose. Do not take more than the maximum allowable dose indicated on your prescription in a 24 hour period. Check your prescription label for the correct dose prescribed by your medical provider.
Storage
Store at room temperature, away from heat and moisture
Keep out of reach of children
Medication Disposal
Do not flush unused medication down the toilet or pour in the sink or drain. Dispose according to local regulations.
Preferred: Use a DEA drug take-back site. If none are available:
Mix medication (liquid or pills—do not crush) with an unappealing substance like dirt, cat litter, or used coffee grounds.
Place in a sealed plastic bag.
Throw away in household trash.
Remove personal information from the bottle before recycling or discarding.
Telemedicine Disclosure: This prescription was issued via telemedicine. If you experience any concerning symptoms, contact your prescribing clinician or seek emergency care.
Disclaimer: This summary does not include all information about Enclomiphene + Supplement Blend. For more details, speak with your healthcare provider or pharmacist.